Stability characterization of controlled release coprecipitates and solid dispersions. Academic Article uri icon

abstract

  • The present study was conducted to determine the effects of ageing at exaggerated storage conditions on controlled release tablets prepared with indomethacin-Eudragit((R)) coprecipitates (CPs) and solid dispersions (SDs). CPs and SDs compressed as tablets were stored at -20, 4, 37, 45, 55, 37 degrees C/11% RH, 37 degrees C/51% RH and 37 degrees C/91% RH. The samples were analyzed over a period of six months for their dissolution, crystalline reversion and thermal changes. Samples stored at extremely low temperatures, higher temperatures and humidity conditions exhibited a significant decrease in dissolution rates. However, no significant change in the release rates was observed for samples stored at 4 degrees C. The degree of crystallinity increased over a period of time as confirmed by X-ray diffractometry. DSC data demonstrated that indomethacin exists in two polymorphic forms, Form I (mp 160-161 degrees C) and Form II (mp 153-154 degrees C). CPs showed an endotherm of Form I, whereas SDs showed a mixture of Form I and II.

published proceedings

  • J Control Release

altmetric score

  • 6

author list (cited authors)

  • Khan, M. A., Karnachi, A. A., Agarwal, V., Vaithiyalingam, S. R., Nazzal, S., & Reddy, I. K.

citation count

  • 21

complete list of authors

  • Khan, MA||Karnachi, AA||Agarwal, V||Vaithiyalingam, SR||Nazzal, S||Reddy, IK

publication date

  • January 2000